Associate Clinical Research Associate (FSP)

Open to Clinical Trial Assistant, Study Coordinator, Regulatory Clinical Trial Coordinator or similar.

Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRA I) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client, and site satisfaction.

As a CRA I at Parexel, you will be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

Position Purpose:

The Clinical Research Associate I (CRAI) with the support of Senior Clinical Research Associate (SCRA), Clinical Research Associate (CRA), Clinical Research Associate - Manager (CRAM) and/or Partner Line Manager (PLM) will act as a primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Primary Duties:

· Develops strong site relationships and ensures continuity of site relationships through all phases

· of the trial.

· Performs clinical study site management/monitoring activities in compliance with ICH-GCP,

Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.

· Gains an in-depth understanding of the study protocol and related procedures.

· Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site ready.

· Participates & provides inputs on site selection and validation activities.

· Performs remote and on-site monitoring & oversight activities using various tools to ensure:

data generated at site are complete, accurate and unbiased, subjects’ right, safety and well-being are protected.

· Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner.

· Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

· Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

· Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate.

· Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. Qualifications

· Minimum 2 + years related clinical research experience, for example: Clinical Trial Assistant, Study Coordinator, Regulatory Clinical Trial Coordinator or similar

· Previous experience in oncology trials or ready to monitor oncology trials.

· Scientific education (e.g. medical, pharmaceutical, biology, biotechnology etc.).

· Preferred: located Northern Poland (Koszalin, Bydgoszcz, Poznań, Trójmiasto) or central Poland.

About ExecuPharm/Parexel FSP

ExecuPharm is a global provider of functional service solutions across a range of specialized disciplines for clinical development and biopharmaceutical product lifecycle support including clinical operations, biometrics, safety, regulatory, medical writing, and medical affairs.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.